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Form of workClinic Research Associate
Michigan Locations: Fraser
Position Summary
Fraser Eye Care Centerhas a rewarding full-time opportunity available for an experienced Clinic Research Associate to join our team. The Research Associate performs a variety of administrative and clinical tasks to assist in the quality and compassionate care of study participants. These responsibilities include recruiting and screening participants, performing intake assessments, work-ups and assisting with data analysis. In addition, maintains organized reports on each study including study protocol, workload and data collection. Acts as a point of reference for study participants by overseeing the schedule, answering questions and keeping participants informed on the study progress. In addition, maintains inventory of supplies related to the study.
Skills Required
- Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
- Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
- Responsible for ensuring appropriate training of all staff to ensure compliance and inspection readiness.
- Work closely with leadership on feasibility and study placement.
- Maintain department operations including research coordination, monitoring, and problem solving.
- Ensure clinical research policies and procedures are maintained.
- Prepare reports and keep upper-level management informed of department operations.
- Ensure weekly, monthly, and quarterly assigned goals are met.
Qualifications
- Bachelor's degree required, Master’s preferred.
- 3-5 years prior experience as a clinical research coordinator.
- 3-5 years of clinical research experience preferred.
- Understanding of medical terminology preferred.
- Experience performing clinical assessments.
- Experience with practice management and electronic medical records (EMR) preferred.
- Knowledge of Good Clinical Practice (GCP) guidelines required.
- Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred.
- Superior analytical skills.
- Advanced written and verbal communication skills.
- Excellent organization and time management skills.
- Demonstrated ability to foster concepts of teamwork, cooperation, and flexibility to get the work done.
- Skilled with standard computer programs including the MS Office and Google Suite(s).
- Ability to travel regionally to attend meetings and training related to studies.
